IPP-ON IPPONINSTP
GUDID 10381780125877
The IPP-ON set includes instruments to be used as a guide for Interphalangeal implants. The interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe.
NEWDEAL
General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit| Primary Device ID | 10381780125877 |
| NIH Device Record Key | a35f8d66-2177-4c0e-b0df-74219b7b1f3a |
| Commercial Distribution Discontinuation | 2023-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | IPP-ON |
| Version Model Number | IPPONINSTP |
| Catalog Number | IPPONINSTP |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780125877 [Primary] |
| HIBCC | M248IPPONINSTP1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103623
FDA Product Code
| HTY | PIN, FIXATION, SMOOTH |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
[10381780125877]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-05-02 |
| Device Publish Date | 2015-09-24 |
Devices Manufactured by NEWDEAL
| M248119580ND1 - I.CO.S® | 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h |
| M248119590ND1 - I.CO.S® | 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h |
| M248139107ND1 - METIS® | 2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im |
| M248529061ND1 - SURFIX® | 2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws. |
| 10381780043317 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
| 10381780043324 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
| 10381780043331 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
| 10381780043348 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
Trademark Results [IPP-ON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IPP-ON 79056207 3576532 Live/Registered |
NEWDEAL 2007-12-13 |
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